{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Newtown",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA207176"
        ],
        "brand_name": [
          "HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"
        ],
        "generic_name": [
          "HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"
        ],
        "manufacturer_name": [
          "KVK-Tech, Inc."
        ],
        "product_ndc": [
          "10702-055"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HOMATROPINE METHYLBROMIDE",
          "HYDROCODONE BITARTRATE"
        ],
        "rxcui": [
          "992656"
        ],
        "spl_id": [
          "47ba86ad-2410-e733-e063-6394a90a24e3"
        ],
        "spl_set_id": [
          "26d7c90c-5e6b-4bdb-b06f-c76173a01c21"
        ],
        "package_ndc": [
          "10702-055-03",
          "10702-055-09",
          "10702-055-01",
          "10702-055-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "68JRS2HC1C",
          "NO70W886KK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87810",
      "recalling_firm": "KVK-Tech, Inc.",
      "address_1": "110 Terry Dr",
      "address_2": "N/A",
      "postal_code": "18940-3427",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0386-2021",
      "product_description": "Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940  NDC 10702-055-03",
      "product_quantity": "17,096 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20210427",
      "center_classification_date": "20210517",
      "termination_date": "20221005",
      "report_date": "20210526",
      "code_info": "Lot: 15684A, Exp 7/2021"
    }
  ]
}